A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
研究概览
简要总结
This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex at birth).
- •Age 18-69 years (both inclusive) at the time of signing the informed consent.
- •Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- •Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening.
- •Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day [(I) U/kg/day] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
- •Any metformin formulation
- •Dipeptidyl peptidase-4 inhibitor (DPP4i)
- •Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
- •Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
- •HbA1c lesser than or equal to (≤) 9.5%
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
研究组 & 干预措施
NNC0471-0119 H then Insulin Aspart
Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
干预措施: NNC0471-0119 H (Drug)
NNC0471-0119 H then Insulin Aspart
Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
干预措施: Insulin Aspart (Drug)
Insulin Aspart then NNC0471-0119 H
Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
干预措施: NNC0471-0119 H (Drug)
Insulin Aspart then NNC0471-0119 H
Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
时间窗: 0 to 1 hour after bolus infusion
Measured in milligram per kilogram (mg/kg).
次要结局
- AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t(0 to 11 hours after bolus infusion)
- AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t(0 to 11 hours after bolus infusion)
- GIR (max,basal-corrected): Maximum observed basal-corrected GIR(0 to 11 hours after bolus infusion)
- AUC(NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t(0 to 11 hours after bolus infusion)
- AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t(0 to 11 hours after bolus infusion)
- AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes(0 to 30 minutes after bolus infusion)
- AUC(NNC0471-0119,2h-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t(2 to 11 hours after bolus infusion)
- AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t(0 to 11 hours after bolus infusion)
- C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration(0 to 11 hours after bolus infusion)
- t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration(0 to 11 hours after bolus infusion)
- t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration(0 to 11 hours after bolus infusion)
- Number of adverse events (AEs)(From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days))